ARx Sr. Scientist

2 weeks ago

Glen Rock, United States ARx, LLC Full time

Job Summary:

Responsible for the design and development of new products, creation of new technologies, and improvements to existing products.



Essential Functions:

Defines project design & strategy consistent with application requirements; reviews and shares with project team members and others in the organization as appropriate.

Develops formulations and related product constructions including selection of raw materials, experimental evaluations (e.g. compatibility, stability, performance, etc.) and specifications; frequently works on more than one project at a time with number depending on scope and timing.

Designs & conducts experiments on lab and production scale; draws valid conclusions upon analysis of technical data from experimental testing, expertise, and literature references.

Defines test methodologies and requirements; prepares test samples and conducts tests on raw materials, in-process intermediates, and/or finished products as required to support programs; develops new tests as necessary to support development or product improvement projects.

Fulfills responsibilities in an efficient and effective manner; makes critical distinctions in support of prioritizing and organizing work; anticipates and proactively addresses potential lab development, scale-up, validation, clinical, regulatory and commercial issues during development.

Efficiently troubleshoots and solves technical problems.

Participates in the design and specification of production-scale processes and validation thereof.

Contributes and represents R&D while serving on cross-functional teams chartered to develop and commercialize new drug delivery products; interacts effectively fulfilling functional responsibilities, collaborating with functional counterparts & customers to assure overall project success.

Researches literature and patents as needed to effectively assure freedom-to-operate and otherwise support projects.

Maintains up-to-date, well-organized, clear and accurate information in lab notebooks and design records consistent with established company & divisional practices.

Supports and contributes to maintaining office and laboratory environment consistent with LEAN 6S and all regulatory requirements.

Interacts with customers as needed to support projects; behaves in a respectful and professional manner and able to earn & maintain the confidence of associates and customers.

Recognizes opportunities for and participates in patenting technology yielding sustainable competitive advantage.

Maintains a current awareness of pharmaceutical and drug delivery technologies to build expertise and applies same to benefit business.

Ensures up-to-date compliance with all training requirements; understands overall business strategy and plans while also working to execute responsibilities in accordance thereof.

Makes identifiable and beneficial contributions to continuous improvement; performs all duties safely and consistent with established company and divisional procedures and guidelines; actively complies with and endorses department, divisional and company objectives.

Responsible for following all applicable waste handling procedures.



Additional Responsibilities:

Benchmarks equipment and systems.

Performs other duties and responsibilities as assigned.



Job Specifications:

PhD. in Pharmaceutical Sciences, Chemistry, Chemical Engineering or Polymer/Materials Science with a minimum of 5 years experience in pharmaceutical and/or drug delivery systems formulation.

Polymer formulation and mixing process experience in drug delivery required with coatings experience preferred; transdermal and/or oral solid dosage form experience preferred; proven track record of successful commercial outcomes desired.

Knowledge of and experience with cGMP, 21CFR Part 211 required; QbD, PAT, ICH & ISO experience additive.

Must communicate fluently in English and have excellent communication and interpersonal skills.

Capable of performing duties independently with limited supervisory direction.

Ability to effectively manage multiple priorities.

Familiarity and aptitude with chemical analytical techniques and associated data analysis.

Working knowledge of statistically-based experimental techniques.

Ability to maintain confidentiality.

Ability to conduct self in a professional manner & maintain appearance accordingly.

Functioning capability with standard computer software (word-processing, spreadsheets, internet & database searching, email, etc.) and Oracle ERP systems.

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